Kneitz C, Fiehn C
Rheumatologische Facharztpraxis Schwerin, Beethovenstr. 3, 18053, Schwerin, Deutschland.
Praxis für Rheumatologie, Tätigkeitsschwerpunkt Klinische Immunologie und Belegarzteinheit der ViDia-Kliniken Karlsruhe, Medical Center Baden-Baden, Baden-Baden, Deutschland.
Z Rheumatol. 2018 Sep;77(7):559-568. doi: 10.1007/s00393-018-0498-2.
The correct use of therapeutic agents in accordance with their approved label is a requirement for a safe therapy and is often linked to the possibility of reimbursement; however, the use of drugs outside the label approval (off-label treatment) is a commonly used practice in rheumatology. This occurs because sufficient clinical trials are often lacking, particularly for rare diseases. This overview gives an insight into the correct use of disease-modifying antirheumatic drugs (DMARDs). It should be noted that there are divergent treatment guidelines that are based on guidelines or recommendations from public authorities, such as the Federal Joint Committee (GBA). A further example is that modifying the dose when the treatment goal is reached is only intended for some of the drugs in the course of the disease. Clinical trials which address such questions could help to modify or add to the label, as for example has now been successfully achieved for the treatment with certolizumab in pregnancy.
按照药品批准标签正确使用治疗药物是安全治疗的要求,并且通常与报销可能性相关;然而,在标签批准范围之外使用药物(即超说明书用药)在风湿病学中是一种常用做法。出现这种情况是因为往往缺乏充分的临床试验,尤其是针对罕见病的试验。本综述深入探讨了改善病情抗风湿药(DMARDs)的正确使用。应当指出,存在基于公共当局(如联邦联合委员会(GBA))的指南或建议的不同治疗指南。另一个例子是,在疾病过程中达到治疗目标时调整剂量仅适用于某些药物。针对此类问题的临床试验有助于修改或补充药品标签,例如现在已成功实现了赛妥珠单抗用于妊娠期治疗的标签修改。